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New pill could keep ovarian cancer at bay for BRCA patients

NCT ID NCT01844986

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether taking olaparib tablets daily can delay the return of advanced ovarian cancer in women with BRCA gene mutations. Participants had already responded to initial platinum chemotherapy. The study compares olaparib to a placebo over up to two years, measuring how long the cancer stays under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Olaparib (a PARP inhibitor taken as a tablet)
What this could lead to
If successful, this could offer a way to keep BRCA-related ovarian cancer from coming back for a longer time after initial chemotherapy.
What could go wrong
This is a maintenance therapy, not a cure. It may only delay progression, not stop it entirely. Side effects like fatigue, nausea, or blood issues are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

450 people

The number who actually took part.

Started

Aug 2013

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female patients with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer and / or fallopian - tube cancer who have completed first line platinum based chemotherapy (intravenous or intraperitoneal). * Stage III patients must have had one attempt at optimal debulking surgery (upfront or interval debulking). Stage IV patients must have had either a biopsy and/or upfront or interval debulking surgery. * Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function). * Patients who have completed first line platinum (e.g. carboplatin or cisplatin), containing therapy (intravenous or intraperitoneal) prior to randomisation: * Patients must have, in the opinion of the investigator, clinical complete response or partial response and have no clinical evidence of disease progression on the post treatment scan or rising CA-125 level, following completion of this chemotherapy course. Patients with stable disease on the post-treatment scan at completion of first line platinum-containing therapy are not eligible for the study. * Patients must be randomized within 8 weeks of their last dose of chemotherapy Exclusion Criteria: * BRCA1 and/or BRCA2 mutations that are considered to be non detrimental (e.g. "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favor polymorphism" or "benign polymorphism" etc). * Patients with early stage disease (FIGO Stage I, IIA, IIB or IIC) * Stable disease or progressive disease on the post-treatment scan or clinical evidence of progression at the end of the patient's first line chemotherapy treatment. * Patients where more than one debulking surgery has been performed before randomisation to the study. (Patients who, at the time of diagnosis, are deemed to be unresectable and undergo only a biopsy or oophorectomy but then go on to receive chemotherapy and interval debulking surgery are eligible). * Patients who have previously been diagnosed and treated for earlier stage ovarian, fallopian tube or primary peritoneal cancer. * Patients who have previously received chemotherapy for any abdominal or pelvic tumour, including treatment for prior diagnosis at an earlier stage for their ovarian, fallopian tube or primary peritoneal cancer. (Patients who have received prior adjuvant chemotherapy for localised breast cancer may be eligible, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease). * Patients with synchronous primary endometrial cancer unless both of the following criteria are met: 1) stage \<2 2) less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with Stage IA grade 1 or 2 endometrioid adenocarcinoma. Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • 1st Hospital of Jilin university

    Changchun, China

  • 69LYON, C Bérard, Onco

    Lyon, France

  • 75PARIS, H Tenon, Onco

    Paris, France

  • Abington Memorial Hospital

    Abington, Pennsylvania, United States

  • Addenbrooke's Hospital

    Cambridge, United Kingdom

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, United States

  • Arden Cancer Centre

    Coventry, United Kingdom

  • Asan Medical Center

    Seoul, South Korea

  • Aultman Hospital

    Canton, Ohio, United States

  • Aurora Baycare Medical Center

    Green Bay, Wisconsin, United States

  • Avera Cancer Institute

    Sioux Falls, South Dakota, United States

  • Azienda Ospedaliera "Cannizzaro"

    Catania, Italy

  • Babak Edraki

    Walnut Creek, California, United States

  • Barcelona,H.Vall d´Hebrón,Oncología

    Barcelona, Spain

  • Bari- Istituto Tumori Giovanni Paolo II

    Bari, Italy

  • Beijing Cancer Hospital

    Beijing, China

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, United States

  • CAC François Baclesse

    Caen, France

  • CHUM - Hopital Norte-Dame

    Montreal, Quebec, Canada

  • Cancer Research Institute

    Saint Petersburg, Russia

  • Cancer Research UK and UCL Cancer Trials Centre

    London, United Kingdom

  • Carilion Clinic Gynecological Oncology

    Roanoke, Virginia, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, United States

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, France

  • Centre Catherine de Sienne

    Nantes, France

  • Centro Diagnóstico Barretos

    Barretos, Brazil

  • Centro de Novos Tratamentos Itajai

    Itajaí, Brazil

  • Centro de Referencia da Saude da Mulher

    São Paulo, Brazil

  • Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

    Warsaw, Poland

  • Chaim Sheba Medical Centre

    Tel Litwinsky, Israel

  • Chemotherapy Department, Russian Cancer Research Centre

    Moscow, Russia

  • ChongQing Cancer Hospital

    Chongqing, China

  • City Hospital, Birmingham, Cancer Trials Team

    Birmingham, United Kingdom

  • Clearview Cancer Institute

    Huntsville, Alabama, United States

  • Cleveland Clinic Cancer Center at Fairview Hospital

    Cleveland, Ohio, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, United States

  • Córdoba,H.Reina Sofía,Oncología

    Córdoba, Spain

  • Dana Farber Cancer Institute

    Boston, Massachusetts, United States

  • Duke University Medical Center

    Durham, North Carolina, United States

  • Edinburgh Cancer Research UK Centre

    Edinburgh, United Kingdom

  • First affiliated hospital college of XianJiaotong University

    Xi'an, China

  • Florida Hospital Cancer Institute

    Orlando, Florida, United States

  • Froedtert Memorial Hospital

    Milwaukee, Wisconsin, United States

  • Gangnam Severance Hospital

    Seoul, South Korea

  • Greater Baltimore Medical Center

    Baltimore, Maryland, United States

  • Gynecologic Cancer Center

    Orlando, Florida, United States

  • Gynecologic Oncology of West MI, PLLC

    Grand Rapids, Michigan, United States

  • H Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, United States

  • H.Llobregat,ICO-Duran i Reynals,Oncología

    Hospitalet deLlobregat(Barcelo, Spain

  • Henry Ford Health System

    Detroit, Michigan, United States

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, United States

  • Hokkaido University Hospital

    Sapporo, Japan

  • Hope Women's Cancer Centers

    Asheville, North Carolina, United States

  • Hospital Araujo Jorge

    Goiânia, Brazil

  • Hospital de Base São José do Rio Preto

    São José do Rio Preto, Brazil

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Brazil

  • Hotel-Dieu de Quebec

    Québec, Quebec, Canada

  • Hunan Cancer Hospital

    Changsha, China

  • Hyogo CC

    Akashi-shi, Japan

  • Indiana University

    Indianapolis, Indiana, United States

  • Institut Bergonie

    Bordeaux, France

  • Institut Gustave Roussy

    Villejuif, France

  • Instituto do Câncer de São Paulo

    São Paulo, Brazil

  • Irmandade da Santa Casa de Misericordia de Porto Alagre

    Porto Alegre, Brazil

  • Istituto Europeo di Oncologia

    Milan, Italy

  • Istituto Nazionale Per Cura Tumori - Milano

    Milan, Italy

  • Istituto Nazionale Tumori Fondazione Pascale

    Naples, Italy

  • Istituto Oncologico Veneto Irccs

    Padova, Italy

  • Istituto Regina Elena-Polo Oncologico Ifo

    Roma, Italy

  • JINAN, Qi Lu Hosp. of SD Univ.

    Jinan, China

  • Jilin Provincial Cancer Hospital

    Changchun, China

  • John Theurer Cancer Center

    Hackensack, New Jersey, United States

  • Johns Hopkins

    Baltimore, Maryland, United States

  • Juravinski Cancer Centre

    Hamilton, Ontario, Canada

  • Kaiser Permanente

    Oakland, California, United States

  • Kaiser Permanente

    Roseville, California, United States

  • Kettering Medical Center

    Kettering, Ohio, United States

  • Korea Cancer Center Hospital

    Seoul, South Korea

  • Leningrad Regional Oncology Dispensary

    Saint Petersburg, Russia

  • Levine Cancer Institute

    Charlotte, North Carolina, United States

  • London Health Sciences Centre

    London, Ontario, Canada

  • MD Anderson Cancer Center

    Houston, Texas, United States

  • MD Anderson at Cooper Cancer Center

    Camden, New Jersey, United States

  • Maastricht Universitair Medisch Centrum

    Maastricht, Netherlands

  • Madrid, MD Anderson, Oncología

    Madrid, Spain

  • Madrid,H.U.La Paz,Oncología

    Madrid, Spain

  • Maine Medical Partners

    Scarborough, Maine, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, United States

  • Mayo Clinic - Rochester, MN

    Rochester, Minnesota, United States

  • McFarland Clinic, P.C.

    Ames, Iowa, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, United States

  • Mercy Hospital for Women

    Heidelberg, Australia

  • Minnesota Oncology Hematology, PA

    Edina, Minnesota, United States

  • Missouri Valley Cancer Consortium CCOP

    Omaha, Nebraska, United States

  • Mount Sinai Medical Center - New York

    New York, New York, United States

  • NHO Kyushu CC

    Fukuoka, Japan

  • NHO Shikoku Cancer Center

    Matsuyama, Japan

  • Nancy N. & J.C. Lewis Cancer and Research Pavillion

    Savannah, Georgia, United States

  • National Cancer Center

    Goyang-si, South Korea

  • National Cancer Center Hosp

    Chūōku, Japan

  • Nebraska Methodist Hospital

    Omaha, Nebraska, United States

  • Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital

    Amsterdam, Netherlands

  • Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna

    Grzepnica, Poland

  • Niigata Univ. Med. Dent.

    Niigata, Japan

  • Northeast Georgia Medical Center

    Gainesville, Georgia, United States

  • Northern Indiana Cancer Research Consortium

    Mishawaka, Indiana, United States

  • Northside Hospital

    Atlanta, Georgia, United States

  • Northwestern University

    Chicago, Illinois, United States

  • Norton Cancer Institute Research

    Louisville, Kentucky, United States

  • Obstetris and Gynecology Hospital of Fudan University

    Shanghai, China

  • Peggy and Charles Stephenson Cancer Center

    Oklahoma City, Oklahoma, United States

  • Perlmutter Cancer Center

    New York, New York, United States

  • Policlinico Universitario A. Gemelli

    Roma, Italy

  • Prince of Wales Hospital

    Randwick, Australia

  • Princess Margaret Cancer Centre

    Toronto, Ontario, Canada

  • Providence Cancer Center

    Anchorage, Alaska, United States

  • Rabin MC

    Petah Tikva, Israel

  • Rambam Health Care Campus

    Haifa, Israel

  • Research Institute of Oncology RAMS

    Tomsk, Russia

  • Research Site

    Columbus, Ohio, 43210, United States

  • Research Site

    Guangzhou, 510060, China

  • Roswell Park Cancer Institute

    Buffalo, New York, United States

  • Royal Marsden Hospital

    London, United Kingdom

  • Royal Marsden Hospital and Institute of Cancer Research

    Sutton, United Kingdom

  • Royal Victoria Hospital

    Montreal, Quebec, Canada

  • SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

    Olsztyn, Poland

  • Saitama Med. Univ. Int. Med. C

    Hidaka-shi, Japan

  • Samsung Medical Center

    Seoul, South Korea

  • Sanford Clinic Women's Health

    Sioux Falls, South Dakota, United States

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, United States

  • Sapir Medical Centre

    Kfar Saba, Israel

  • Seoul National University Hospital

    Seoul, South Korea

  • Shanghai Cancer Hospital of Fudan University

    Shanghai, China

  • Shizuoka Cancer Center

    Sunto-gun, Japan

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut, United States

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina, United States

  • St. Joseph's Hospital & Medical Center

    Phoenix, Arizona, United States

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania, United States

  • St. Vincent Hospital & Health Care Center

    Indianapolis, Indiana, United States

  • St.Petersburg City Oncology Dispensary, Dept. Gynecology

    Saint Petersburg, Russia

  • Stanford Women's Cancer Center

    Stanford, California, United States

  • State Institution of Heath Omsk Regional Oncology Dispensary

    Omsk, Russia

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, Canada

  • Szpital Specjalistyczny im. Swietej Rodziny SPZOZ

    Warsaw, Poland

  • Tel-Aviv Sourkasy Medical Center

    Tel Aviv, Israel

  • The First Affiliated Hospital of Soochow Universit

    Suzhou, China

  • The Queen's Medical Center

    Honolulu, Hawaii, United States

  • The Royal Womens Hospital

    Parkville, Australia

  • The Tumor Hospital affiliated to China Medical Science Insti

    Beijing, China

  • The Tumour Hospital of Harbin Medical University

    Harbin, China

  • The University of Pennsylvania

    Philadelphia, Pennsylvania, United States

  • UNC Chapel Hill

    Chapel Hill, North Carolina, United States

  • Udmurtia Republic Clinical Oncology Center

    Izhevsk, Russia

  • Univ Chicago Medical Center

    Chicago, Illinois, United States

  • Univ of Connecticut Health Center

    Farmington, Connecticut, United States

  • University Hospital Case Medical Center

    Cleveland, Ohio, United States

  • University of California, Los Angeles

    Los Angeles, California, United States

  • University of Colorado

    Aurora, Colorado, United States

  • University of Hawaii

    Honolulu, Hawaii, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, United States

  • University of New Mexico

    Albuquerque, New Mexico, United States

  • University of Texas Health Science Center of Houston

    Houston, Texas, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, United States

  • University of Virginia

    Charlottesville, Virginia, United States

  • University of Wisconsin-Madison

    Madison, Wisconsin, United States

  • Valencia, IVO, Oncología

    Valencia, Spain

  • Valencia,H.C.U.Valencia,Oncología

    Valencia, Spain

  • Virginia Oncology Associates

    Norfolk, Virginia, United States

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, United States

  • Washington University School of Medicine

    St Louis, Missouri, United States

  • West China Hospital Affiliated to Sichuan University

    Chengdu, China

  • Wojewódzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, Poland

  • Women and Infants Hospital

    Providence, Rhode Island, United States

  • Women's Cancer Care Associates

    Albany, New York, United States

  • Women's Hospital, Zhejaing University School of Medicine

    Hangzhou, China

  • Womens Cancer Center of Nevada

    Las Vegas, Nevada, United States

  • Zhejiang Cancer Hospital, Huangzhou

    Huangzhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.